We are currently working with a Biotech company who is transferring products from the US to their new HQ in Bern. They have just build a new production line to facilitate this move which is exciting.
Requirements:
- Absolute expertise in Process Validation required
- Experience in GMP environment: > 5 years
Tasks:
- Writing of Process Risk Assessment (CQAs/ CPPs)
- Writing of Characterization Plans/ Protocols/ Reports
- Writing of Process Validation Plans/ Protocols/ Reports
- Writing of Deviations/ OOS/ Investigations from Characterization/ Validations
- Defining of corrective and preventive measures (CAPAs) and follow up on those
- Participation in regular Validation meetings
- Potentially Writing of change controls
- Writing/ adapting of SOPs and Work Instructions
- Potential support with Cleaning- or Hold Time Validations
Language:
- English, German is a bonus